Septopal Side Effects

Note: This page contains side effects data for the generic drug gentamicin. It is possible that some of the dosage forms included below may not apply to the brand name Septopal.

For the Consumer

Applies to gentamicin: injection injectable, injection solution

As well as its needed effects, gentamicin (the active ingredient contained in Septopal) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking gentamicin, check with your doctor or nurse immediately:

Incidence not known:

Abdominal or stomach cramps or pain

agitation

back pain

black, tarry stools

blood in the urine

blurred or double vision

burning, numbness, tingling, or painful sensations

change in frequency of urination or amount of urine

chest pain

chills

coma

confusion

continuing ringing or buzzing or other unexplained noise in the ears

cough

difficult or troubled breathing

difficulty with swallowing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

drowsiness

dry mouth

eye pain

fast heartbeat

fever with or without chills

hallucinations

headache

hearing loss

hives

hoarseness

increased thirst

irregular heartbeats

irregular, fast or slow, or shallow breathing

irritability

itching

joint pain

loss of appetite

mood or mental changes

muscle cramps in the hands, arms, feet, legs, or face

muscle pain or weakness

muscle spasms (tetany) or twitching

nausea or vomiting

nervousness

numbness and tingling around the mouth, fingertips, or feet

pale or blue lips, fingernails, or skin

pale skin

pinpoint red spots on the skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

right upper abdominal or stomach pain and fullness

seizures

sensation of spinning

skin rash

slow or fast heartbeat

slow or irregular breathing

sore throat

sores, ulcers, or white spots on the lips or in the mouth

stiff neck

sweating

swelling of the feet or lower legs

swollen glands

tightness in the chest

trembling

unusual bleeding or bruising

unusual tiredness or weakness

weight chest discomfort

weight loss

wheezing

Minor Side Effects

Some gentamicin side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

For Healthcare Professionals

General

The most frequently reported adverse effects associated with gentamicin (the active ingredient contained in Septopal) therapy are ototoxicity and nephrotoxicity. These forms of toxicity occur more frequently in patients who experience prolonged exposure to serum gentamicin trough concentrations of greater than 2 mcg/mL. Patients with renal insufficiency are at an increased risk of developing toxicity.[Ref]

Renal

Acute renal failure due to gentamicin (the active ingredient contained in Septopal) is usually nonoliguric with an average rise in serum creatinine of 1 to 3 mg/dL. Renal function generally returns to baseline in 7 to 14 days. Rarely, gentamicin produces renal tubular acidosis and renal potassium and magnesium wasting. There is no relationship between acute renal failure and the daily dose of gentamicin, however, an increased incidence has been associated with a serum trough gentamicin concentration greater than 2 mcg/mL. It has been suggested that there is a correlation between the higher peak concentrations associated with once-daily dosing and a higher incidence of nephrotoxicity. Other predisposing factors include advanced age, preexisting renal insufficiency, dehydration, and concomitant use of other potentially nephrotoxic drugs.[Ref]

Renal side effects associated with gentamicin use have included nephrotoxicity. The overall incidence of aminoglycoside nephrotoxicity is 2% to 10%. Gentamicin nephrotoxicity occurs in two forms: acute renal failure (ARF), and a more gradual, transient, and reversible azotemia. Fanconi syndrome and Bartter-like syndrome have been reported.[Ref]

Nervous system

The onset of ototoxicity may be asymptomatic or may manifest as dizziness, vertigo, ataxia, tinnitus, and roaring in the ears. High tone hearing loss is often an early symptom of auditory toxicity. It has been suggested that once-daily dosing of gentamicin (the active ingredient contained in Septopal) is associated with a higher incidence of ototoxicity.

Other side effects possibly related to gentamicin have included lethargy, confusion, depression, headache, pseudotumor cerebri, and acute organic brain syndrome.[Ref]

Nervous system side effects have included ototoxicity, which generally presents as loss of vestibular function secondary to hair cell damage, but may also be auditory. Ototoxicity is closely related to the development of renal impairment, and may be irreversible. Peripheral neuropathy or encephalopathy with numbness, skin tingling, muscle twitching, seizures, and myasthenia gravis-like syndrome have also been reported.

Intraventricular and intrathecal administration of gentamicin has rarely been associated with aseptic meningitis, transient hearing loss, and seizures. Neuromuscular side effects including ataxia, paresis and incontinence have been reported after large intrathecal doses (40 mg to 160 mg) of preservative-containing gentamicin. Concurrent administration of parenteral and intrathecal gentamicin has been associated with eighth nerve dysfunction, fever, convulsions, leg cramps, and increases in cerebrospinal fluid protein.[Ref]

Musculoskeletal

Musculoskeletal side effects have rarely included neuromuscular blockade, which occurs most commonly in patients who are predisposed including patients with myasthenia gravis, hypocalcemia, and those receiving a concomitant neuromuscular blocking agent. Tetany and muscle weakness may be associated with gentamicin-induced hypomagnesemia, hypocalcemia, and hypokalemia. Joint pain has also been reported.[Ref]

Respiratory

Respiratory side effects have included case reports of respiratory depression and respiratory arrest. Gentamicin (the active ingredient contained in Septopal) has also been possibly associated with pulmonary fibrosis.[Ref]

Hypersensitivity

Hypersensitivity reactions possibly associated with gentamicin (the active ingredient contained in Septopal) have included anaphylactoid reactions and laryngeal edema. Suspected allergic reactions against gentamicin with sodium metabisulfite preservative have been reported.[Ref]

Local

Local reactions have occasionally included pain at the injection site, and rarely subcutaneous atrophy or fat necrosis at the injection site. Reactions associated with intrathecal injections have included arachnoiditis and burning at the injection site.[Ref]

Dermatologic

Dermatologic side effects possibly associated with gentamicin (the active ingredient contained in Septopal) have included rash, itching, urticaria, generalized burning, and alopecia.[Ref]

Hepatic

Hepatic side effects possibly related to gentamicin (the active ingredient contained in Septopal) use have included transient hepatomegaly, and increases in serum transaminase, serum LDH, and bilirubin.[Ref]

Cardiovascular

Cardiovascular side effects possibly related to gentamicin (the active ingredient contained in Septopal) have included hypotension and hypertension.[Ref]

Ocular

Ocular side effects have included case reports of retinal ischemia resulting in loss of visual acuity after inadvertent intraocular injection of massive doses of gentamicin (the active ingredient contained in Septopal) [Ref]

Other

Other side effects possibly related to gentamicin (the active ingredient contained in Septopal) have included transient splenomegaly and fever.[Ref]

Pyrogenic reactions with symptoms of shaking, chills, fever, rigors, tachycardia, and/or hypotension have been reported with intravenous gentamicin. These reactions generally occurred within 3 hours of administration and were believed to be due to once-daily gentamicin doses delivering sufficient endotoxin over one hour to be pyrogenic.[Ref]

12. Falagas ME, Matthaiou DK, Bliziotis IA "The role of aminoglycosides in combination with a beta-lactam for the treatment of bacterial endocarditis: a meta-analysis of comparative trials." J Antimicrob Chemother 57 (2006): 639-47

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